The ATC by Pfeiffer Vacuum Mass Extraction leak testing process meets FDA standard F3287 for leak testing. This shortens the FDA approval process for pharmaceutical products that require leak testing significantly. However, with ATC being added to the FDA standard, companies do not need to submit paperwork regarding leak test, test procedure, water ingress, and package testing manufacturers can simply declare that their product is leak tested in accordance with FDA F3287 by using ATC equipment, thus adhering to the standard.
USP 1207 and ASTM (F-3287–17) recognized ATC Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defects and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for use in production environments allowing stability control as well as 100% automated testing (also in inline machines).
